NCT01668147

Brief Summary

To determine the effects of ritonavir and efavirenz on the activity of P-glycoprotein in human brain.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Aug 2012

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 30, 2012

Completed
2 days until next milestone

Study Start

First participant enrolled

August 1, 2012

Completed
16 days until next milestone

First Posted

Study publicly available on registry

August 17, 2012

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
3.5 years until next milestone

Results Posted

Study results publicly available

January 22, 2020

Completed
Last Updated

January 22, 2020

Status Verified

January 1, 2020

Enrollment Period

3.8 years

First QC Date

July 30, 2012

Results QC Date

June 21, 2018

Last Update Submit

January 8, 2020

Conditions

Drug Effects

Keywords

PET ImagingEfavirenzRitonavir[11C] desmethyl-loperamideHealthy volunteers

Outcome Measures

Primary Outcomes (1)

  • Cerebral [11C]dLop Distribution Volume

    1 day

Study Arms (3)

Control

EXPERIMENTAL

Session 1: Control (no pretreatment) - IV 10-14 mCi of \[11C\] desmethyl-loperamide (dLop) with PET/CT imaging

Drug: [11C] desmethyl-loperamideOther: Control - no pretreatment

Oral ritonavir

ACTIVE COMPARATOR

Session 2: Pretreatment with oral ritonavir for 3 days followed by IV 10-14 mCi of \[11C\]dLop with PET/CT imaging

Drug: [11C] desmethyl-loperamideDrug: Oral ritonavir

Oral efavirenz

ACTIVE COMPARATOR

Session 3: Pretreatment with oral efavirenz for 14 days followed by IV 10-14 mCi of \[11C\]dLop with PET/CT imaging

Drug: [11C] desmethyl-loperamideDrug: Oral efavirenz

Interventions

[11C] desmethyl-loperamideDRUG

IV administration of 10-14 mCi of \[11C\] desmethyl-loperamide with PET/CT imaging

ControlOral efavirenzOral ritonavir
Control - no pretreatmentOTHER

Session 1: IV administration of 10-14 mCi \[11C\] desmethyl-loperamide (dLop) with PET/CT imaging and brain MRI

Control
Oral ritonavirDRUG

Session 2: Pretreatment with oral ritonavir for 3 days followed by IV administration of 10-14 mCi \[11C\]dLop with PET/CT imaging and brain MRI

Oral ritonavir
Oral efavirenzDRUG

Session 3: Pretreatment with oral efavirenz for 14 days followed by IV administration of 10-14 mCi \[11C\]dLop with PET/CT imaging and brain MRI

Oral efavirenz

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Male or non-pregnant female, 18-40 yr old
  • Good general health with no remarkable medical conditions
  • BMI \< 33
  • Provide informed consent

You may not qualify if:

  • Known history of liver or kidney disease
  • History of major medical conditions
  • HIV seropositive
  • Fasting blood glucose \> 110 mg/dl
  • Family history of type 2 diabetes
  • Use of prescription or non prescription medications, herbals or foods known to be metabolized by or altering P-glycoprotein or CYP3A activity (hormonal birth control medications are acceptable if alternative means of contraception are used)
  • Females who are pregnant or nursing
  • Females taking hormonal contraceptives who are unwilling to use alternative means of contraception
  • Contraindications to MRI
  • Contraindications to PET scanning

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Interventions

N-demethylloperamideRitonavirefavirenz

Intervention Hierarchy (Ancestors)

ThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Results Point of Contact

Title
Evan Kharasch MD PhD
Organization
Washington University
kharasch@wustl.edu
3143628796

Study Officials

  • Evan Kharasch, MD, PhD.

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 30, 2012

First Posted

August 17, 2012

Study Start

August 1, 2012

Primary Completion

June 1, 2016

Study Completion

August 1, 2016

Last Updated

January 22, 2020

Results First Posted

January 22, 2020

Record last verified: 2020-01

Locations

US(1)